Regulatory Affairs Director

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Responsibilities Key roles and responsibilities include, but are not limited to the following: 1. Portfolio Management - Oversee and is accountable for regulatory strategy, risk mitigation and HA interactions of product portfolios, ensuring alignment with organization objectives and regulatory requirements. - Ensure regulatory activities through the product life cycle, including CTA, initial licensure and later management are appropriately actioned and managed. - Collaborate with and influence industry associations and Health Authorities on key portfolio and regulatory policy matters - Act as an advisor for the member of the Portfolio Team to consult with and a subject matter expert in regulatory strategy, and lead/contribute to the generation of regulatory knowledge and insights. - Accountable for building partnerships with PDR global and key stakeholders from other functions to ensure the strategic business goals/prioritizations alignment, issue escalation and conflict solving. - Establish fit-for-purpose ways of working and effectiveness of the Portfolio Team 2. People Management - Ensure the necessary regulatory science knowledge and multiple sub-function domain expertise and resources are available to deliver the work and foster growth and development of the team - Responsible for leading (VACC), mentoring, and developing a diverse team of professionals within the product and community matrix. - Role model and supports talent flow within, into, and out of the portfolio team - Builds an implementable and robust succession plan for the future Portfolio Team Lead - Foster a culture of transparency, accountability, innovation, and continuous learning; boost team members to take ownership of their development and contributions. - Manage team performance, including goal setting and regular evaluations, ensuring the long-term success of both individuals and the organization. 3. Community Management - Build, nurture, and lead cross-team communities that drive collaboration, knowledge sharing, and innovation across the organization. - Act as a central point of contact within the community matrix, aligning community initiatives with function goals and ensuring consistent communication and engagement across teams. - Develop and implement strategies that enhance community cohesion, break down silos, and create an environment where all members can contribute to the organization’s success. Requirements/qualifications: The ideal person for this role will have the following experience, skills and attributes: - Proven experience in drug development, a deep understanding of the regulatory science/requirements, full product lifecycle and the ability to manage complex product portfolios. - Demonstrated expertise in people management, with a strong track record of leading, developing, and retaining high-performing teams. - Experience or track record of managing dynamic cross-functional projects/initiatives, which require great collaboration, engagement, and knowledge sharing across diverse teams. - Strong leadership, communication, and organizational skills, with the ability to influence and inspire stakeholders internally and externally, including NMPA and its affiliated organizations. - The candidate should have a University or higher degree in pharmaceutical or life sciences with 10+ years of experience in R&D based pharmaceutical companies. - The candidate is open minded and collaborative with a growth mindset and purpose-led. - Excellent Chinese and English verbal and written communication skills Application Instructions Qualified candidates are invited to submit their resume outlining their relevant experience and why they are a perfect fit for this multifaceted role. Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.